A Study to Evaluate the Efficacy and Safety of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME

Korábbi kezelés

• Have any treatment for complications of cataract surgery with steroids or yttrium aluminum garnet (YAG) laser capsulotomy within 90 days of Screening

Más betegség

• History of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening

Laborértékek

• Are currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)
• If treatment-experienced for DME have a history of any of the following treatments within the noted time windows:
  • Have had prior treatment in the study eye with 8 mg aflibercept (EYLEA HD) or faricimab (VABYSMO) within 120 days prior to the Screening visit in the study eye
  • Have had an IVT with other anti-VEGF treatments (ranibizumab, bevacizumab, aflibercept [2 mg], brolucizumab, pegaptanib sodium) in the study eye within 90 days of the Screening visit

Egyéb

• Be pregnant or breastfeeding

• Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
• Be male or female ≥18 years of age.
• Have type 1 or type 2 diabetes mellitus and a hemoglobin A1c (HbA1c) of ≤12%.
• Have a decrease in vision in the study eye determined by the investigator to be primarily the result of diabetic macular edema (DME).